Biomarkers in demand but CROs cautious, study

Demand for biomarker analysis is strong, but the pace of technological change is causing an investment headache for CROs according to a new report by Industry Standard Research (ISR).

The research, “The State of Biomarkers in Drug Development,” examined the attitudes of 37 top pharmaceutical and biotechnology companies with regard to the use of biomarkers in clinical development.

ISR president Kevin Olson told Outsourcing-pharma that the results indicate that although demand is generally quite strong “[it] somewhat depends on the type of biomarker and type of analysis we're talking about.

“We've found that surrogate biomarkers, those used as substitutes for clinical endpoints, are currently the most widely adopted,” explained Olson, adding that over 70 per cent of respondents reported using such an approach.

CROs delaying investment

The other key finding is that despite recent moves by larger players like Quintiles
, Covance
, Wuxi
and Parexel
, in general contract research organisations (CRO) are yet to fully embrace biomarker analysis as a standard service offering.

“One of the big issues,” Olson explained “is that the technology is changing so rapidly that investing in a platform or hard assets is risky. Your investment might be profitable for a while or might get ‘leap-frogged’ by the next generation or a scientific discovery.”

He went on to say that this uncertainty, coupled with the drug industry’s traditionally conservative attitude to new technologies, means that “CROs have a difficult time balancing the desire to differentiate their service offerings by being innovators with the need to be fiscally responsible.

“If [a CROs] offerings are too far out in front of demand, they're using resources that they can hardly risk at a time when their margins are being squeezed as they are currently. So estimating their customers' speed of adoption of new technologies is critical for them.”

Predictive biomarker growth

Despite this, ISR’s results still indicate that use of biomarker technologies and testing will increase rapidly through to 2013.

Olson suggested that: “Perhaps the most notable increase will come from predictive biomarkers, those that indicate a likely response to a specific therapy.

He added that while only 33 per cent of respondents said that use predictive biomarkers at present, 70 per cent indicated they are likely to make “substantial” use of them over the next few years.

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